ACTIVE_NOT_RECRUITING

Tirzepatide for Obesity and Meth Use Disorder

Conditions

Obesity Methamphetamine Use Disorder Methamphetamine MUD Overweight Tirzepatide Weight management

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label pilot study to evaluate the feasibility and preliminary efficacy of using tirzepatide when prescribed for its United States (US) Food and Drug Administration (FDA)-approved weight-related indication in individuals with comorbid methamphetamine use disorder.

Official Title

Tirzepatide for Individuals With Comorbid Obesity and Methamphetamine Use Disorder

Quick Facts

Study Start:2025-02-03

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06745128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be 18 to 65 years of age, inclusive. 2. Be able to provide informed consent and ask relevant questions. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. 4. Be willing to adhere to the study medication regimen 5. Meet DSM-5 criteria for moderate or severe methamphetamine use disorder. 6. Self-report methamphetamine use on 18 or more days in the 30-day period prior to written informed consent using the Timeline Followback (TLFB). 7. Have an initial body mass index (BMI) at screening of: 1. 30 kg/m2 or greater (obesity) 2. 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease). 8. If biologically female and is or becomes sexually active with a biological male, must agree to use acceptable methods of contraception and have urine pregnancy testing during participation in the study, unless unable to get pregnant 9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration	1. Current or recent use (within 3 months prior to consent) of other tirzepatide-containing products or any other GLP-1 receptor agonist 2. Current or recent use (within 30 days) of sulfonylureas, other concomitantly administered insulin secretagogue, or insulin 3. Current or recent use (within 3 months prior to consent) of other weight loss agents 4. Weight loss surgery within 12 months prior to consent 5. Current eating disorder per clinician evaluation 6. Personal or family history of Medullary Thyroid Carcinoma 7. History of Multiple Endocrine Neoplasia syndrome type 2 8. Known serious hypersensitivity (e.g., anaphylaxis, angioedema) to tirzepatide or any of the excipients in tirzepatide 9. History of angioedema or anaphylaxis with a GLP-1 receptor agonist 10. Current Stage 3 or higher Chronic Kidney Disease, defined as eGFR \<60 at Screening 11. Current inadequately controlled diabetes, defined as HbA1c \> 7.0 at Screening 12. History of diabetic retinopathy 13. Current pregnancy or lactation 14. Treatment with another investigational drug or intervention within the past one month (30 days prior to consent) 15. Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee. 16. Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.

Inclusion Criteria

Exclusion Criteria

1. Be 18 to 65 years of age, inclusive.
2. Be able to provide informed consent and ask relevant questions.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Be willing to adhere to the study medication regimen
5. Meet DSM-5 criteria for moderate or severe methamphetamine use disorder.
6. Self-report methamphetamine use on 18 or more days in the 30-day period prior to written informed consent using the Timeline Followback (TLFB).
7. Have an initial body mass index (BMI) at screening of:
1. 30 kg/m2 or greater (obesity)
2. 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease).
8. If biologically female and is or becomes sexually active with a biological male, must agree to use acceptable methods of contraception and have urine pregnancy testing during participation in the study, unless unable to get pregnant
9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

1. Current or recent use (within 3 months prior to consent) of other tirzepatide-containing products or any other GLP-1 receptor agonist
2. Current or recent use (within 30 days) of sulfonylureas, other concomitantly administered insulin secretagogue, or insulin
3. Current or recent use (within 3 months prior to consent) of other weight loss agents
4. Weight loss surgery within 12 months prior to consent
5. Current eating disorder per clinician evaluation
6. Personal or family history of Medullary Thyroid Carcinoma
7. History of Multiple Endocrine Neoplasia syndrome type 2
8. Known serious hypersensitivity (e.g., anaphylaxis, angioedema) to tirzepatide or any of the excipients in tirzepatide
9. History of angioedema or anaphylaxis with a GLP-1 receptor agonist
10. Current Stage 3 or higher Chronic Kidney Disease, defined as eGFR \<60 at Screening
11. Current inadequately controlled diabetes, defined as HbA1c \> 7.0 at Screening
12. History of diabetic retinopathy
13. Current pregnancy or lactation
14. Treatment with another investigational drug or intervention within the past one month (30 days prior to consent)
15. Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee.
16. Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.

Contacts and Locations

Principal Investigator

Manish Jha, M.B.B.S.

PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center

Dallas, Texas, 75247

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Manish Jha, M.B.B.S., PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2025-02-03

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

Methamphetamine
Methamphetamine Use Disorder
MUD
Overweight
Obesity
Tirzepatide
Weight management

Additional Relevant MeSH Terms

Obesity
Methamphetamine Use Disorder